Therapeutic agent preparations into a lumen of the intestinal tract using a swallowable drug delivery device

Abstract

Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Many embodiments provide a swallowable device for delivering the agents. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade within the wall to release the drug to produce a therapeutic effect. The preparation can be coupled to an actuator having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the intestinal wall. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

What is claimed is: 
     
       1. A method for delivering a therapeutic agent into a wall of a lumen of the gastro-intestinal (GI) tract of a patient, the method comprising: swallowing a drug delivery device having an interior, an actuator having a first configuration and a second configuration and a therapeutic preparation operably coupled to the actuator, the therapeutic preparation comprising a therapeutically effective dose of at least one therapeutic agent, the preparation being contained within the device interior in the first configuration and advanced out of the interior and into the GI lumen wall in the second configuration so as to deliver the preparation into the lumen wall, the preparation supplied in the device in a shaped form which can be delivered from the device into the wall of GI lumen by the application of force on the preparation; and
 actuating the actuator responsive to a condition in the GI lumen to deliver the therapeutic preparation from the device into the wall of the GI lumen or adjacent tissue. 
 
     
     
       2. The method of  claim 1 , wherein the GI lumen is the patient's stomach and the therapeutic preparation degrades within a wall of the stomach to release the therapeutic agent into the patient's blood stream. 
     
     
       3. The method of  claim 1 , wherein the condition in the GI lumen is a presence of GI fluid. 
     
     
       4. The method of  claim 1 , wherein the therapeutic preparation comprises at least one pharmaceutical excipient. 
     
     
       5. The method of  claim 1 , wherein at least a portion of the therapeutic preparation is shaped as a tissue penetrating member advanceable into the lumen wall. 
     
     
       6. The method of  claim 5 , wherein the tissue penetrating member has a pointed tip. 
     
     
       7. The method of  claim 1 , wherein the actuator is a spring. 
     
     
       8. The method of  claim 7 , wherein the spring is a coil spring. 
     
     
       9. The method of  claim 1 , wherein the therapeutic agent comprises a therapeutically effective dose of insulin for the treatment of diabetes or other glucose regulation disorder. 
     
     
       10. The method of  claim 9 , wherein the dose of insulin is in a range from about 4 to 9 units of insulin. 
     
     
       11. The method of  claim 9  further comprising: using the dose of delivered insulin to control a blood glucose level of a patient without externally injecting insulin into the patient. 
     
     
       12. The method of  claim 1 , wherein the therapeutic agent comprises a therapeutically effective dose of an incretin for the treatment of diabetes or other glucose regulation disorder. 
     
     
       13. The method of  claim 12 , further comprising: using the dose of delivered incretin to control a blood glucose level of a patient without externally injecting incretin into the patient. 
     
     
       14. The method of  claim 12 , wherein the incretin comprises a glucagon like peptide-1 (GLP-1), a GLP-1 analogue, exenatide, liraglutide, albiglutide, taspoglutide or a gastric inhibitory polypeptide (GIP). 
     
     
       15. The method of  claim 1 , wherein the therapeutic agent comprises a combination of therapeutic agents for the treatment of diabetes or other glucose regulation disorder. 
     
     
       16. The method of  claim 15 , further comprising: using the dose of delivered therapeutic agents to control a blood glucose level of a patient without externally injecting the dose of therapeutic agents into the patient. 
     
     
       17. The method of  claim 15 , wherein the combination of therapeutic agents comprises a therapeutically effective dose of an incretin and a therapeutically effective dose of insulin. 
     
     
       18. The method of  claim 15 , wherein the combination comprises a therapeutically effective dose of an incretin and a therapeutically effective dose of a biguanide. 
     
     
       19. The method of  claim 18 , wherein the incretin comprises exenatide and the biguanide comprises metformin. 
     
     
       20. The method of  claim 1 , wherein the therapeutic agent comprises a therapeutically effective dose of growth hormone for the treatment of a growth disorder. 
     
     
       21. The method of  claim 20 , further comprising: using the dose of delivered growth hormone to treat the growth disorder without externally injecting growth hormone into the patient. 
     
     
       22. The method of  claim 1 , wherein the therapeutic agent comprises a therapeutically effective dose of parathyroid hormone for the treatment of osteoporosis or a thyroid disorder. 
     
     
       23. The method of  claim 22 , further comprising: using the dose of delivered parathyroid hormone to treat the osteoporosis or thyroid disorder without injecting parathyroid hormone into the patient. 
     
     
       24. The method of  claim 1 , wherein the therapeutic agent comprises a therapeutically effective dose of a chemotherapeutic agent for the treatment of cancer. 
     
     
       25. The method of  claim 24 , wherein the chemotherapeutic agent comprises interferon. 
     
     
       26. The method of  claim 1 , wherein the therapeutic agent comprises a therapeutically effective dose of an antibiotic. 
     
     
       27. The method of  claim 1 , wherein the therapeutic agent comprises a therapeutically effective dose of an antiviral compound. 
     
     
       28. The method of  claim 1 , wherein the therapeutic agent comprises a therapeutically effective dose of an immune suppressive agent. 
     
     
       29. The method of  claim 1 , wherein the therapeutic agent comprises a therapeutically effective dose of an anti-migraine agent. 
     
     
       30. The method of  claim 1 , wherein the therapeutic agent comprises a therapeutically effective dose of an anti-seizure agent for the treatment of epilepsy or other seizure disorder.